Table 3.
RECIST v1.1 | mRECIST | |||||
---|---|---|---|---|---|---|
IMbrave150 in (n = 38) | IMbrave150 out (n = 66) | p-Value | IMbrave150 in (n = 38) | IMbrave150 out (n = 66) | p-Value | |
ORR (%) | 18.4% | 19.7% | 1.000 | 29.0% | 27.3% | 1.000 |
DCR (%) | 81.6% | 78.8% | 0.804 | 73.7% | 78.8% | 0.631 |
1st line (n = 48) | 2nd line- (n = 56) | p-value | 1st line (n = 48) | 2nd line- (n = 56) | p-value | |
ORR (%) | 18.8% | 19.6% | 1.000 | 31.3% | 25.0% | 0.517 |
DCR (%) | 81.3% | 78.6% | 0.809 | 75.0% | 78.6% | 0.816 |
Child-Pugh A (n = 96) | Child-Pugh B (n = 8) | p-value | Child-Pugh A (n = 96) | Child-Pugh B (n = 8) | p-value | |
ORR (%) | 20.8% | 0.0% | 0.349 | 28.1% | 25.0% | 1.000 |
DCR (%) | 79.2% | 87.5% | 1.000 | 77.1% | 75.0% | 1.000 |
Proteinuria 0-1+ (n = 91) | Proteinuria 2+ (n = 7) | p-value | Proteinuria 0-1+ (n = 91) | Proteinuria 2+ (n = 7) | p-value | |
ORR (%) | 18.7% | 28.6% | 0.618 | 27.5% | 28.6% | 1.000 |
DCR (%) | 82.4% | 85.7% | 1.000 | 79.1% | 85.7% | 1.000 |
Platelet ≧ 7.5 × 104/μL (n = 98) | Platelet < 7.5 × 104/μL (n = 6) | p-value | Platelet ≧ 7.5 × 104/μL (n = 98) | Platelet < 7.5 × 104/μL (n = 6) | p-value | |
ORR (%) | 18.4% | 33.3% | 0.325 | 26.5% | 50.0% | 0.345 |
DCR (%) | 79.6% | 83.3% | 1.000 | 77.6% | 66.7% | 0.620 |
1st–2nd line (n = 85) | 3rd line (n = 19) | p-value | 1st–2nd line (n = 85) | 3rd line (n = 19) | p-value | |
ORR (%) | 21.2% | 10.5% | 0.355 | 31.8% | 10.5% | 0.089 |
DCR (%) | 78.8% | 84.2% | 0.758 | 74.1% | 89.5% | 0.230 |
Viral (n = 51) | Non-viral (n = 53) | p-value | Viral (n = 51) | Non-viral (n = 53) | p-value | |
ORR (%) | 17.7% | 20.8% | 0.805 | 23.5% | 32.1% | 0.386 |
DCR (%) | 80.4% | 79.3% | 1.000 | 72.6% | 81.1% | 0.356 |
BCLC-B (n = 41) | BCLC-C (n = 63) | p-value | BCLC-B (n = 41) | BCLC-C (n = 63) | p-value | |
ORR (%) | 19.5% | 19.0% | 1.000 | 34.2% | 23.8% | 0.271 |
DCR (%) | 87.5% | 76.4% | 0.290 | 87.5% | 72.2% | 0.130 |
mALBI 1-2a (n = 73) | mALBI 2b (n = 31) | p-value | mALBI 1-2a (n = 73) | mALBI 2b (n = 31) | p-value | |
ORR (%) | 21.9% | 12.9% | 0.416 | 31.5% | 19.4% | 0.240 |
DCR (%) | 78.1% | 83.9% | 0.600 | 76.7% | 77.4% | 1.000 |
<50% liver involvement (n = 90) | ≧50% liver involvement (n = 14) | p-value | <50% liver involvement (n = 90) | ≧50% liver involvement (n = 14) | p-value | |
ORR (%) | 20.0% | 14.3% | 1.000 | 26.0% | 14.3% | 0.340 |
DCR (%) | 80.0% | 78.6% | 1.000 | 76.7% | 78.6% | 1.000 |
Up-to-7 in (n = 27) | Up-to-7 out (n = 77) | p-value | Up-to-7 in (n = 27) | Up-to-7 out (n = 77) | p-value | |
ORR (%) | 40.7% | 11.7% | 0.003 | 48.2% | 20.8% | 0.002 |
DCR (%) | 88.9% | 76.6% | 0.265 | 85.2% | 74.0% | 0.296 |
Vp − (n = 88) | Vp + (n = 16) | p-value | Vp − (n = 88) | Vp + (n = 16) | p-value | |
ORR (%) | 21.6% | 6.3% | 0.298 | 31.8% | 6.3% | 0.037 |
DCR (%) | 83.0% | 62.5% | 0.087 | 79.6% | 62.5% | 0.194 |
Abbreviations: ORR: objective response rate, DCR: disease control rate, BCLC: Barcelona Clinic Liver Cancer, mALBI: modified albumin-bilirubin grade, Vp: portal vein invasion.